Mariane D.

Experienced Regulatory Affairs and Quality professional with a strong background in end-to-end FDA Philippines processes across Drugs, Food, Cosmetics, HUHS, and Medical Devices. Acts as the main liaison for FDA-related transactions, including LTO, CPR, CPN, Batch Notifications, and technical dossier submissions. Skilled in managing renewals, ensuring regulatory compliance, and reviewing product labeling and documentation. Also proficient in healthcare data stewardship, responsible for validating and updating HCP and HCO records through structured research and direct outreach. Background includes hands-on experience in pharmaceutical quality control, performing chemical analysis, stability testing, and operating instruments such as HPLC and spectrophotometers. Demonstrated expertise in method validation, troubleshooting, and preparing analytical reports.